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Evaluation of Messenger RNA From COVID-19 BTN162b2 and mRNA-1273 Vaccines in Human Milk

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

Messenger RNA (mRNA) vaccines against COVID-19 were recently approved under an emergency use authorization.1 However, there is a paucity of data regarding vaccine safety in pregnant or lactating individuals who were excluded from phase 3 clinical trials,2,3 and many mothers have declined vaccination or decided to discontinue breastfeeding (temporarily or permanently) due to concern that maternal vaccination may alter human milk. The World Health Organization recommends that breastfeeding individuals be vaccinated and does not advise cessation of breastfeeding following vaccine administration.4,5 The Academy of Breastfeeding Medicine states that there is little plausible risk that vaccine nanoparticles or mRNA would enter breast tissue or be transferred to milk,6 which could theoretically result in priming of infant immune responses that could alter childhood immunity. However, there are no direct data. To address this knowledge gap, we analyzed milk samples to determine if vaccine-related mRNA was detectable in human milk after vaccination.

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Article Information

Accepted for Publication: April 26, 2021.

Published Online: July 6, 2021. doi:10.1001/jamapediatrics.2021.1929

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Golan Y et al. JAMA Pediatrics.

Corresponding Author: Stephanie L. Gaw, MD, PhD, Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, 513 Parnassus Ave, HSE16, PO Box 0556, San Francisco, CA 94143 (stephanie.gaw@ucsf.edu).

Author Contributions: Drs Golan and Gaw had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: All authors.

Acquisition, analysis, or interpretation of data: Golan, Prahl, Cassidy, Lin, Gaw.

Drafting of the manuscript: Golan, Cassidy, Ahituv, Gaw.

Critical revision of the manuscript for important intellectual content: Prahl, Cassidy, Lin, Ahituv, Flaherman, Gaw.

Statistical analysis: Golan, Cassidy, Gaw.

Obtained funding: Golan, Prahl, Ahituv.

Administrative, technical, or material support: Golan, Cassidy, Lin, Ahituv, Flaherman, Gaw.

Study supervision: Prahl, Ahituv, Gaw.

Conflict of Interest Disclosures: Dr Prahl has received grants from the National Institutes of Health and Marino Family Foundation. Dr Golan has received a postdoctoral fellowship from the International Society for Research In Human Milk and Lactation and Human Frontier Science Program. Dr Flaherman has received grants from the Bill and Melinda Gates Foundation, US Centers for Disease Control and Prevention (CDC) Foundation, Robert Wood Johnson Foundation, California Health Care Foundation, and Yellow Chair Foundation. Dr Gaw has received grants from the National Institutes of Health, Bill and Melinda Gates Foundation, CDC Foundation, Robert Wood Johnson Foundation, California Health Care Foundation, and Yellow Chair Foundation. No other disclosures were reported.

Funding/Support: This study was supported by the Marino Family Foundation (Dr Prahl), the National Institutes of Health (grant K23AI127886 to Dr Prahl and grant K08AI141728 to Dr Gaw), the Weizmann Institute of Science–National Postdoctoral Award Program for Advancing Women in Science (Dr Golan), the International Society for Research In Human Milk and Lactation Trainee Bridge Fund (Dr Golan), and the Human Frontier Science Program (Dr Golan).

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We acknowledge the milk donors that volunteered for this study. We thank Kenneth Scott, BS, RPh, (UCSF Health Pharmacy, University of California, San Francisco) and Hannah J. Jang, PhD, RN, PHN, CNL (UCSF School of Nursing, University of California, San Francisco), for voluntarily providing unused vaccine for this study. We also thank Caryl Gay, PhD (Department of Family Health Care Nursing, UCSF School of Nursing, University of California, San Francisco), and Ifeyinwa V. Asiodu, PhD, RN, IBCLC (Department of Family Health Care Nursing, UCSF School of Nursing, University of California, San Francisco), for voluntary assistance with participant questionnaires and support of the study. Contributors were not compensated for their work.

References
1.
Center for Biologics Evaluation and Research. Emergency Use Authorization for Vaccines to Prevent COVID-19. Accessed March 27, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19
2.
Polack  FP , Thomas  SJ , Kitchin  N ,  et al; C4591001 Clinical Trial Group.  Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine.   N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577PubMedGoogle ScholarCrossref
3.
Baden  LR , El Sahly  HM , Essink  B ,  et al; COVE Study Group.  Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine.   N Engl J Med. 2021;384(5):403-416. doi:10.1056/nejmoa2035389PubMedGoogle ScholarCrossref
4.
World Health Organization. Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19. Accessed March 27, 2021. https://www.who.int/publications/i/item/interim-recommendations-for-use-of-the-moderna-mrna-1273-vaccine-against-covid-19
5.
Strategic Advisory Group of Experts on Immunization. Background document on mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19. Accessed March 27, 2021. https://www.who.int/publications/i/item/background-document-on-mrna-vaccine-bnt162b2-(pfizer-biontech)-against-covid-19
6.
Academy of Breastfeeding Medicine. ABM Statement: considerations for COVID-19 vaccination in lactation. Accessed February 13, 2021. https://abm.memberclicks.net/abm-statement-considerations-for-covid-19-vaccination-in-lactation
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